Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K260850
Device Name OSTEOMNI SPINAL CAGES SYSTEM
Applicant
Osteomni, Inc.
9956 NW 89th Ct.
Medley,  FL  33178
Applicant Contact Gulten Shurdom
Correspondent
Osteomni, Inc.
9956 NW 89th Ct.
Medley,  FL  33178
Correspondent Contact Gulten Shurdom
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   MQP   OVE   PLR  
Date Received03/16/2026
Decision Date 05/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-